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OpenTrials
Completed

NCT Number: NCT00667654

Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)

This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Phamacology Study Group

Worcester, Massachusetts, 01610, United States

About this study

This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged 40 years or over.
  • Body mass index (BMI) of 35 or less.
  • History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
  • X-Ray of the target knee.
  • Willing and able to complete the study procedures.

Exclusion criteria

  • Female patients who are pregnant or lactating or who plan to get pregnant.
  • Clinically significant form of joint disease other than OA.
  • Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
  • Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
  • Arthroscopic surgery on the target knee within 6 months.

Treatment and study plan

CNTX-4975

Drug

Testing a range of dosing configurations to optimize patient tolerability

Primary outcomes

  1. To evaluate the safety of IA CNTX-4975 as measured by related AEs occurring on day of dosing measures of pain at prescribed times

    Time frame: 12 Weeks

Secondary outcomes

  1. Evaluate analgesic efficacy, as measured by the PGIC, following IA injection of CNTX-4975

    Time frame: 12 Weeks

  2. Change from baseline to Week 12 in WOMAC subscale score

    Time frame: Baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

Centrexion Therapeutics

Industry

Registry information

Official study title

A Phase 2, Open-label Study to Evaluate Safety and Tolerability, and to Explore the Efficacy, of Dosing Regimens of Intraarticular 4975 in Patients With Chronic Moderate to Severe Pain of the Knee Associated With Osteoarthritis

Important dates

Study start
2007
Primary completion
2008
Study completion
2016
First posted
Apr 28, 2008
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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